Coxsackie B Series CF Antigens
FDA 510(k) K850003 · Hillcrest Biologicals
510(k) numberK850003
Submission
- Device name
- Coxsackie B Series CF Antigens
- Applicant
- Hillcrest Biologicals
Cypress, CA, US - Received
- January 2, 1985
- Decision date
- March 5, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GNG – Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3145
- Specialty
- Microbiology
Other 510(k)s with product code GNG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K921618 | Coxsackie Virus B1-B6 CF AntigensGNG · Traditional | Virion (U.S.), Inc. | 06/29/1992SE |
More from Virion (U.S.), Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K913618 | Arbovirus Igm Ifa TestGQC · Traditional | 12/03/1992SE |
| K913617 | Arbovirus Igg Ifa TestGQC · Traditional | 12/03/1992SE |
| K922374 | Q Fever Igm Ifa TestGPJ · Traditional | 10/21/1992SE |
| K913906 | Q Fever Igg Ifa TestGPJ · Traditional | 10/21/1992SE |
| K900206 | Lyme Disease Igm ElisaLSR · Traditional | 06/28/1991SE |
| K896594 | Ebv Vca Antibody (Igm)LJN · Traditional | 01/16/1990SE |
| K884829 | Ebv Early Antigen (R+D)JRY · Traditional | 04/12/1989SE |
| K883767 | Lyme Disease Ifa (Igm)LSR · Traditional | 03/15/1989SE |
| K884591 | Ebv-Vca Antibody (Igg)GNP · Traditional | 01/24/1989SE |
| K883487 | Lyme Disease Ifa (Igg)LSR · Traditional | 12/13/1988SE |
Questions and answers
When was Coxsackie B Series CF Antigens cleared by the FDA?
Coxsackie B Series CF Antigens (K850003) received a 510(k) decision of Substantially Equivalent on March 5, 1985, 62 days after the submission was received.
What is the product code of K850003?
The FDA product code is GNG – Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6, a Class I (low risk) device regulated under 21 CFR 866.3145.